The present invention, in some embodiments thereof, relates to the field of prosthetic implants, and more particularly, to an Ostomy containment device for use following Ostomy cases such as Colostomy, Ileostomy or Urostomy, and fecal incontinence.
An Ostomy is a surgical procedure wherein an opening (stoma) is created in the body, for example, for the discharge of body wastes. Common types of ostomies are colostomy, ileostomy and urostomy. The colostomy is a surgical procedure involving forming a stoma, generally from an end or from the side of a healthy portion of the large intestine, by diverting the large intestine to the abdominal wall. The ileostomy is a surgical procedure involving forming a stoma, generally from an end or from the side of a healthy portion of the ileum in the small intestine, usually by diverting the small intestine to the abdominal wall (frequently in the groin area of the wall). The urostomy is a surgical procedure which diverts urine away from a diseased or defective bladder, and generally includes removing a section at the end of the small intestine (ileum) or at the beginning of the large intestine (cecum), and relocating the section as a conduit for urine to pass from the kidneys to the outside of the body through a stoma in the abdominal wall. In some cases, a stoma may be permanent, for example where it is no longer possible for the intestinal content to pass out via the anus (e.g. due to colon cancer, diverticulitis, trauma, inflammatory bowel disease, etc.). Optionally, the stoma may be temporary, for example following an operation on a section of the bowel (small intestine and/or large intestine) where the section may require a period of time for healing.
Following a stoma operation, an Ostomy containment system or its portion may be used to control the flow of body waste through the stoma. The Ostomy containment system may be a non-irrigation system which includes use of a pouch in which feces or urine is collected; or an irrigation system which includes means for washing out the bowel without the use of a pouch. In the non-irrigation system the pouch generally requires emptying or changing several times a day, depending on a frequency of bowel activity. In the irrigation system, a removable closure such as a gauze cap may be placed over the stoma, and irrigation is performed by inserting a catheter inside the stoma and flushing with water. This allows the body waste to flow out of the body into an irrigation sleeve or bag. Irrigation may generally be performed once a day, although the frequency may vary according to the person, location of the stoma, food intake, and health of the person. An alternative arrangement for an ostomy containment system includes implementation of an artificial sphincter, either implanted or externally attached to the stoma, by which the user can shut-off or enable the flow of body waste out of the stoma.
U.S. Pat. No. 5,197,984 discloses “A shut-off device particularly useful as an artificial sphincter for shutting-off the flow from a passage in a subject's body includes a conduit assembly attachable to the body with its inner end in alignment with the passage, a ring rotatably mounted in the outer end of the conduit assembly, and an elastomeric sleeve passing through the conduit assembly and ring, with the inner end of the sleeve attached to the inner end of the conduit assembly, and the outer end of the sleeve attached to the ring. The pliable sleeve is of a length such that the ring may be rotated with respect to the conduit assembly to twist the pliable sleeve from an untwisted open condition permitting the flow of the material from the body passage, to a twisted closed condition shutting-off the flow of the material.”
U.S. Pat. No. 4,351,322 discloses “A stoma control device and method are disclosed. The device comprises, in combination, a support such as a ring for surgical implantation in the body beneath the abdominal wall and substantially around the emerging bowel of a stoma, the support being formed of a relatively soft material such as soft plastic and having an inner surface which tapers outwardly to present a relatively large supporting surface for the bowel, and a plug adapted to be received in the stoma and within the bowel for controlling the stoma, the plug including an inflatable balloon, the balloon, on inflation, presenting an outwardly tapered surface with a shape which complements the tapered inner surface of the support whereby during control of the stoma with the device a relatively large surface of the bowel may be greatly compressed between the plug and the support so as to minimize pressure and tissue destruction.”
U.S. Pat. No. 4,204,282 discloses “An implantable artificial sphincter in the form of a sleeve for receiving and supporting therein the remaining terminal end of healthy bowel tissue. The sleeve is provided with multiple openings therethrough for the growth and passage of anchoring fibrous granulation tissue and the sleeve is provided with a removable closure which is position in the patient at the point were the anal sphincter was surgically removed thereby providing an artificial sphincter in near normal anatomical position.”
U.S. Pat. No. 4,121,589 discloses “An Ostomy appliance comprises an attachment portion having an aperture therethrough adapted to register with an opening in the body of a patient and having adhesive on one face thereof adapted to secure the attachment portion to the body of the patient surrounding the opening, the attachment portion being provided on the opposite face thereof with structure for securing a cap member in sealing relationship thereto over the aperture; and a cap member comprising a generally concave body member of rigid or semi-rigid material, the body member containing absorbent material for absorbing drainage and/or discharge from the opening and being provided with structure engaging the attachment portion for securing said cap member to said attachment means. The appliance may further include an absorber member adapted to be inserted into the opening through the aperture in the attachment portion, the absorber member comprising a generally tubular absorption and storage member having inner and outer walls of fluid pervious material, the inner and outer walls being separated by absorbent material, and a flange at one end of the tubular member to retain the absorber member in position in the opening on securing the cap member to the attachment portion.”
WO 96/32904 discloses “The problem which is solved by a prosthesis for bowel evacuation control at the incontinence of an artificial or natural anus in accordance with the invention is how to provide simple, safe and reliable control of bowel evacuation in artificial or natural incontinence, where under artificial incontinence colostomy, i.e. a surgically formed opening in the large intestine through the abdominal wall is understood, and under natural incontinence the incontinence of the anal sphincter is understood. The illustrated prosthesis inserted in a colostomy, i.e. a bowel (1) extended through the abdominal wall (2), consists of an inner ring (3) which continues into a pellicular tube (4) and this into a faceplate (5), and of a cover (8). In this embodiment the inner ring (3) is carried out as a ring made of pliable, organism-friendly material with a built-in reinforcement (9) providing a sufficient force for reexpansion of the ring (3) and preventing its deformation when being inserted into the bowel lumen. The inner ring (3) continues along its entire circumference into the tube (4) whose thin walls are made of a material with similar characteristics as the inner ring (3). The diameter of an unstretched tube (4) is a little smaller than the diameter of the inner ring (3). The length of the tube (4) in this embodiment is a little smaller than the thickness of the abdominal wall (2). At the end lying opposite to the inner ring (3) the tube (4) continues into a faceplate (5) which is preferably of circular form and made of firm material or dimensioned so that it is firm yet pliable. The plate (5) has an opening in the centre in which the cover (8) is inserted which prevents the feces from escaping.”
Additional background art includes the following U.S. Pat. Nos. 4,766,845; 2,510,766; 2,544,579; 2,931,353; 3,447,533; 3,802,418; 4,0350,500; 4,192,785; 4,209,010; 4,981,465; 4,634,443; 4,551,862; 5,045,052; 5,569,216; 6,485,476; 7,087,041; 4,209,010; 4,210,132; 4,399,809; 6,033,390; 4,619,245; and 2,457,244.